Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
NCT ID: NCT00549874
Last Updated: 2007-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2002-02-28
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Rosiglitazone
oral 8 mg/once daily for 6 months
2
Glyburide
20 mg/ once daily for 6 months
Interventions
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Rosiglitazone
oral 8 mg/once daily for 6 months
Glyburide
20 mg/ once daily for 6 months
Eligibility Criteria
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Inclusion Criteria
* 30-75 years of age
* less than 1% fluctuation in HbA1c over 3 months
* women must be on contraception
* HbA1c 6-9%
* willingness to sign approved consent form
Exclusion Criteria
* Subjects requiring insulin therapy (\>20 units/day) and can not be converted to sulfonylurea therapy without loss of diabetes control.
* Patients with a history of drug or alcohol dependence in the last 5 years
* Patients with pre-existing cardiovascular disease including coronary artery disease, heart attack, heart failure, abnormal heart rhythms, structural abnormalities and valve disease, peripheral vascular disease and uncontrolled high blood pressure.
* Patients with a history of high cholesterol requiring therapy.
* Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy
* Patients currently taking drugs which act on the blood vessels (for example for hypertension)
* Patients taking antidepressants, or other drugs or medications known to interfere with the uptake or metabolism of catecholamines (stress hormones)
* Patients with poor renal function or have significant liver disease
* Patients with a history of previous kidney, pancreas or cardiac transplantation.
* Patients with a history of "severe hypoglycemia" which required the assistance of a third party or ketoacidosis requiring hospital admission within the last 3 months.
* Patients with lung disease for example resulting from chronic obstructive airways disease.
* Patients with abnormal thyroid function tests.
* Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study.
* Patients with a history of allergic reactions to multiple drugs or biological products.
* Obese patients (BMI greater than 35).
* Patients who refuse to sign the informed consent.
30 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
University of Michigan
OTHER
Principal Investigators
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Martin Stevens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
University of Toledo - Health Campus
Toledo, Ohio, United States
Countries
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References
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Pop-Busui R, Oral E, Raffel D, Byun J, Bajirovic V, Vivekanandan-Giri A, Kellogg A, Pennathur S, Stevens MJ. Impact of rosiglitazone and glyburide on nitrosative stress and myocardial blood flow regulation in type 2 diabetes mellitus. Metabolism. 2009 Jul;58(7):989-94. doi: 10.1016/j.metabol.2009.02.020.
Other Identifiers
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SKB 276
Identifier Type: -
Identifier Source: org_study_id